(68 days)
No
The summary describes a mechanical implant system for treating femoral neck fractures and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for treating femoral neck fractures, which is a therapeutic purpose.
No
The device description indicates that the Femoral Neck System is comprised of implants and insertion instruments designed to treat femoral neck fractures, explicitly stating it is a "fixed-angle gliding fixation device." This describes a therapeutic, rather than a diagnostic, function. The "Intended Use / Indications for Use"section also states it is "indicated for femoral neck fractures," which refers to treatment, not diagnosis.
No
The device description explicitly states it is comprised of implants and system-specific insertion instruments, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Femoral Neck System is comprised of implants designed to treat femoral neck fractures. These are physical devices surgically implanted into the body.
- Intended Use: The intended use is to treat femoral neck fractures, which is a structural issue with bone, not a diagnostic test performed on a sample.
The device is a surgical implant used for orthopedic fixation, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The subject Femoral Neck System is comprised of implants designed to treat femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral neck. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck
Indicated Patient Age Range
adults and adolescents (12-21)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The evaluation of simulated device volumes in the femoral neck and head demonstrates that the subject device does not present a new worst case for use in femoral neck fracture fixation compared to the predicate and reference devices. Hence it supports the proposed expanded 'Indications for Use' for the subject device.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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October 16, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Synthes (USA) Products, LLC Stephan Jepards Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K182154
Trade/Device Name: Depuy Synthes Femoral Neck System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: August 8, 2018 Received: August 9, 2018
Dear Stephan Jepards:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Peter G. Allen -S 2018.10.16 09:51:40 -04'00'
- FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name DePuy Synthes Femoral Neck System
Indications for Use (Describe)
The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Sponsor | DePuy Synthes
Contact: Stephan Jepards
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 32 720 41 59 |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | October 15, 2018 |
| Proprietary Name | DePuy Synthes Femoral Neck System |
| Common Name | Multiple component metallic bone fixation appliance |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: KTT |
| Primary predicate
device | Smith & Nephew PERI-LOC Proximal Femur Locking Bone Plates (K112406) |
| Predicate device | Stryker Omega 3 System (K062066)
DePuy Synthes Femoral Neck System (K172872) |
| Reference device | Asnis III 6.5mm Cannulated Screw (K024060) |
| Device Description | The subject Femoral Neck System is comprised of implants designed to treat femoral
neck fractures as well as system-specific insertion instruments. The Femoral Neck
System is a modular system consisting of four connected implant components forming
a fixed-angle gliding fixation device which allows for controlled collapse of the
femoral neck.
The implants are manufactured from Titanium Alloy and are provided in a range of
dimensions. The same construct can be used for the left and right femur. |
| Indications for use | The Femoral Neck System (FNS) is indicated for femoral neck fractures, including
basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in
which the growth plates have fused or will not be crossed. |
| Technological
characteristics of the
new device compared to
the predicate devices | The Smith & Nephew PERI-LOC Proximal Femur Locking Bone Plates (K112406)
is a multiple component device including a variety of plate, cannulated locking and
non-locking screw and cable saddle designs and sizes. |
| | The Stryker Omega 3 System (K062066) is a compression screw system designed to
treat various types of fractures of the proximal and distal femur.
The Femoral Neck System is a modular system consisting of four connected implant
components forming a fixed-angle gliding fixation device which allows for controlled
collapse of the femoral neck.
Any differences in technological characteristics from the predicate device do not
raise any new questions of safety and effectiveness. |
| Non-clinical
Performance Data | The evaluation of simulated device volumes in the femoral neck and head
demonstrates that the subject device does not present a new worst case for use in
femoral neck fracture fixation compared to the predicate and reference devices. Hence
it supports the proposed expanded 'Indications for Use' for the subject device. |
| Clinical Performance
Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The subject system has similar intended use and indications for use compared to the
predicate device. |
| | The non-clinical performance data included in this submission supports that any
differences in technological characteristics from the predicate device do not raise
any new questions of safety and effectiveness. |
| | It is concluded that the information provided in this submission supports substantial
equivalence. |
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